NCT07754175

Brief Summary

A Multicenter, Open-Label, Single-Arm Extension Study to Evaluate the Safety and Efficacy of FURESTEM-OA-Kit Inj. in Knee Osteoarthritis Patients Who Received Placebo in the K0701 Phase 2a Trial

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
67mo left

Started Jul 2026

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jul 2026Feb 2032

Study Start

First participant enrolled

July 20, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2032

Last Updated

August 10, 2026

Status Verified

July 1, 2026

Enrollment Period

5.5 years

First QC Date

August 4, 2026

Last Update Submit

August 4, 2026

Conditions

Knee Osteoarthritis

Keywords

FURESTEM-OA Kit Inj.Knee Osteoarthritis Stem cell

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Event, AESI(Adverse Event of Special Interest)

    5 years follow-up after treatment

Secondary Outcomes (7)

  • Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Month 3, Month 6, Month 12, Month 24, Month 60 after treatment

  • Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)

    Month 3, Month 6, Month 12, Month 24, Month 60 after treatment

  • Changes in 100-mm VAS

    Month 3, Month 6, Month 12, Month 24, Month 60 after treatment

  • Changes in International Knee Documentation Committee Scoring System (IKDC)

    Month 3, Month 6, Month 12, Month 24, Month 60 after treatment

  • Evaluation of International K&L grade(X-ray)

    Month 12, Month 24 after treatment

  • +2 more secondary outcomes

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who received placebo in the K0701 clinical trial, completed the long-term follow-up study, and voluntarily provided written informed consent to participate in this extension study.

You may qualify if:

  • Participants who received placebo in the K0701 clinical trial and completed the Long-term follow-up study
  • Participants who voluntarily provide written informed consent to participate in this extension study

You may not qualify if:

  • Participants meeting any of the following criteria:
  • Participants whom the investigator considers unsuitable for participation in this extension study.
  • Pregnant or breastfeeding women, and women of childbearing potential or men who do not agree to use an appropriate method of contraception during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHA University Bundang Medical Center

Seoul, South Korea

RECRUITING

Kyung Hee University Hospital

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kyoung Ho Yoon, professor (CI)

    Kyung Hee University Hospital

    PRINCIPAL INVESTIGATOR

  • Sang Hak Lee, professor

    Gangdong Kyunghee University Hospital

    PRINCIPAL INVESTIGATOR

  • Jang Ki Mo, professor

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

  • Sang Gyun Kim, professor

    National medical center

    PRINCIPAL INVESTIGATOR

  • Seok jung Kim, professor

    The Catholic University of Korea, Uijeongbu St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

  • Jae Young Park, professor

    CHA University Bundang Medical Center

    PRINCIPAL INVESTIGATOR

  • Sung Hwan Kim, professor

    Severance Hospital, Yonsei University College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moonkyoung Kim

CONTACT

02-2036-7526mkkim@kangstem.com

Yeonsil Yu

CONTACT

02-2036-7571yuys@kangstem.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 10, 2026

Study Start

July 20, 2026

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

February 28, 2032

Last Updated

August 10, 2026

Record last verified: 2026-07

Locations

KR(2)